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Range of services
- Integrated Clinical Study Reports according to the ICH E3 Guideline and sponsor SOPs
- Clinical Study Protocols
- Clinical Expert Reports
- Investigator's Brochures, INDs and other types of summary documents
- Publications in the field of Clinical Pharmacology
- Advisory services (study design, regulatory affairs etc)
- Key monitoring visits, CRF design, study coordination
Professional career and academic studies
- Independent freelance medical writer and consultant for Clinical Pharmacology since 1995
- Two years' training in toxicology and neuropharmacology in the pharmaceutical industry
- Four years' employment at a full-service CRO focussing on Phase I projects (planning, clinical conduct, biostatistical analysis, medical writing) in different positions, finally as head of the Department of Biometrics and Reporting
- Study of medicine at Hanover Medical School and the University of Heidelberg, Germany
- Four-year degree in psychology from the Technical University of Braunschweig, Germany
Professional associations
- Member of the European Medical Writers Association (EMWA)
- Member of the American Medical Writers Association (AMWA)
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